Why is drug development and research in the context of rare disease frequently more difficult to address? In this blog, we will outline some of the challenges with rare disease programs. What is a rare disease? Simply put, a rare disease or condition is one that...
For Sponsors planning to manufacture or distribute a medical device in the US, understanding regulatory requirements is of the utmost importance. Medical device development and approval are regulated by the FDA, under the jurisdiction of the Center for Devices and...
How to Train Users on the Clinical Trial Information System (CTIS) Ahead of New Regulations On 31 July 2021, the European Commission published a notice in the Official Journal of the European Union announcing that the EU Portal and Database, a key component of the...
For its leadership and culture as a clinical research organization (CRO) in the pharmaceutical industry, MMS has received much recognition and praise recently. To uncover some of the reasons behind this success, we recently sat down with Prasad M. Koppolu, Chief...
FSP partnership models, when developed to find the right level of oversight, scale, pricing, and governance to meet a Sponsor’s needs, offer a functional provider solution that can benefit an organization in a rapidly evolving pharmaceutical industry. For example, The...
Attention Sponsors, Be Prepared to Publish Your Interim Clinical Study Results Right now, imagining that Sponsors would be required to publish the results of their interim analysis before the end of the study seems impossible. However, this will eventually become an...
Combination Products: Understanding and Appreciation of CMC Regulatory Considerations for Successful Submission Planning Whitepaper [Fill out the form below to access the whitepaper] Combination products have emerged as powerful technologies for delivering...
Over the past year, many professionals in clinical research have had to navigate through uncharted waters and adapt to remote auditing due to the COVID-19 pandemic. While the landscape of auditing has changed, the basics of confirming compliance remains the...
Clinical research is very complex, mainly because the questions we answer are almost always multivariate problems, and machine learning can aid clinical researchers in making sense of it. Subjects in a clinical trial differ by myriad factors. Age, gender, and weight...